Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-30

Study Completion Date

2021-09-29

Brief Summary

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This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia

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Detailed Description

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Conditions

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Dyslipidemias Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuampin 10/5mg

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Group Type EXPERIMENTAL

Rosuampin 10/5mg

Intervention Type DRUG

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Rosuampin 20/5mg

Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Group Type EXPERIMENTAL

Rosuampin 20/5mg

Intervention Type DRUG

Rosuampin 20/5mg qd for 8 weeks

Amlodipine/Atorvastatin 5/20mg

Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Group Type ACTIVE_COMPARATOR

Amlodipine/Atorvastatin 5/20mg

Intervention Type DRUG

Amlodipine/Atorvastatin 5/20mg qd for 8 weeks

Interventions

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Rosuampin 10/5mg

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Intervention Type DRUG

Rosuampin 20/5mg

Rosuampin 20/5mg qd for 8 weeks

Intervention Type DRUG

Amlodipine/Atorvastatin 5/20mg

Amlodipine/Atorvastatin 5/20mg qd for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Both man and woman who is over 19 years old
* Patient with dyslipidemia and hypertension
* Written informed consent

Exclusion Criteria

* Triglyceride ≥ 400 mg/dL at screening
* Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors
* sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
* A history of rhabdomyolysis, myopathy
* Patient with hypersensitivity to Statin or Amlodipine
* Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening
* AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
* Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range)
* Contraindications stated in the Label of Rosuampin or Caduet
* Those participating in other clinical trials for investigational products at screening
* Patients deemed to be ineligible to participate in the trial by investigator

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No